Cleared Traditional

Access Free T4

K240273 · Beckman Coulter, Inc. · Chemistry
Mar 2024
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K240273 is an FDA 510(k) clearance for the Access Free T4, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on March 6, 2024, 35 days after receiving the submission on January 31, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K240273 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2024
Decision Date March 06, 2024
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEC — Radioimmunoassay, Free Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1695